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Akebia continues to publish important results of FO2CUS trial to further physicians' understanding of Vafseo® (vadadustat)
CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the American Journal of Kidney Disease has published the results of FO2CUS, an open-label study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent (ESA) to three times weekly oral vadadustat dosing for the maintenance treatment of anemia.
The article titled, "Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD," is available here.
Vafseo® (vadadustat) was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. Vafseo is approved for once-daily oral administration and is expected to be available in the U.S. in January 2025.
"The publication of the FO2CUS data in the American Journal of Kidney Disease is an important milestone and demonstrates Akebia's commitment to both research and to continuing to publish findings from its Vafseo trials," said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia.
FO2CUS was an open-label, active-controlled, sponsor-blinded study that evaluated 456 hemodialysis patients who were randomized (1:1:1) into vadadustat 600mg, vadadustat 900mg, or a long-acting ESA (Mircera®) treatment arms. The primary efficacy endpoint was the mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 20-26). The secondary efficacy endpoint was the mean change in Hb between baseline and the secondary evaluation period (weeks 46-52). The top-line results of the FO2CUS study are available here.
First published in 1981, the American Journal of Kidney Diseases is the official journal of the National Kidney Foundation. AJKD is recognized worldwide as a leading source of information devoted to clinical nephrology research and practice. Articles selected for publication in AJKD undergo a rigorous peer review and editorial consideration process, including statistical review where appropriate, supporting the journal's goal to communicate important new information in clinical nephrology in a way that strengthens knowledge and helps physicians to provide their patients with the highest standard of care.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.
INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Limitations of Use
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS |
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's expectations as to the timing of the market availability of Vafseo in the U.S. and Akebia's commitment to both research and to continuing to publish findings from its Vafseo trials. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Vafseo; the competitive landscape for Vafseo; the ability of Akebia to attract and retain qualified personnel; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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SOURCE Akebia Therapeutics, Inc.